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XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization (XLIMIT)

Primary Purpose

Coronary Artery Disease

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Xlimus DES Implantation during coronary angioplasty

Synergy DES Implantation during coronary angioplasty

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age≥18
Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
PCI considered appropriate and feasible
Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length);
Patient provides written informed consent
Patient agrees to all required follow-up procedures and visits.
Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm

Exclusion Criteria:

The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods;
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
Previous coronary intervention on target vessel in the 3-months prior to enrollment;
Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
Previously documented left ventricular ejection fraction (LVEF) <30%;
Evident cardiogenic shock before randomization;
Patients with left main stem stenosis (>50% by visual estimate);
In-stent restenosis;
ST-segment elevation MI;
Chronic total occlusion/ heavily calcified lesions
Culprit lesion to a Saphenous Vein graft

Sites / Locations

IRCCS Policlinico S. Donato
Hospital Bellvitge
Hospital de la Santa Creu i Sant Pau
Hospital La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XLIMUS DES

Synergy DES

Arm Description

Xlimus DES Implantation during coronary angioplasty

Synergy DES Implantation during coronary angioplasty

Outcomes

Primary Outcome Measures

In-stent neointimal volume

In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups.

Secondary Outcome Measures

Neointimal area

Neointimal area calculated at the site of minimal lumen area measured with OCT

Number of Target lesion failure

composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)

Number of patients experiencig Cardiac death

Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death

Number of Target-vessel Myocardial infarction

any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction

Number of Target-lesion revascularization

repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI

Number of Stent thrombosis

This is defined according to classification proposed by the Academic Research Consortium

Percentage of Device success at 24 hours

deployment of the assigned stents without system failure or device-related complication

Percentage of Lesion success at 24 hours

attainment of <50% residual stenosis of the target lesion using post-PCI

Percentage of Procedural success at 24 hours

lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay

Full Information

NCT ID

NCT03745053

First Posted

November 9, 2018

Last Updated

March 14, 2022

Sponsor

Cardionovum GmbH

Collaborators

Mediolanum Cardio Research

1. Study Identification

Unique Protocol Identification Number

NCT03745053

Brief Title

XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

Acronym

XLIMIT

Official Title

XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 5, 2019 (Actual)

Primary Completion Date

March 2, 2021 (Actual)

Study Completion Date

April 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardionovum GmbH

Collaborators

Mediolanum Cardio Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

Detailed Description

The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized multi-centre controlled trial

Masking

Outcomes Assessor

Masking Description

The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XLIMUS DES

Arm Type

Experimental

Arm Description

Xlimus DES Implantation during coronary angioplasty

Arm Title

Synergy DES

Arm Type

Active Comparator

Arm Description

Synergy DES Implantation during coronary angioplasty

Intervention Type

Device

Intervention Name(s)

Xlimus DES Implantation during coronary angioplasty

Intervention Description

Xlimus DES Implantation during coronary angioplasty

Intervention Type

Device

Intervention Name(s)

Synergy DES Implantation during coronary angioplasty

Intervention Description

Synergy DES Implantation during coronary angioplasty

Primary Outcome Measure Information:

Title

In-stent neointimal volume

Description

Time Frame

6-month follow-up

Secondary Outcome Measure Information:

Title

Neointimal area

Description

Neointimal area calculated at the site of minimal lumen area measured with OCT

Time Frame

6-month follow-up

Title

Number of Target lesion failure

Description

composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)

Time Frame

12-months follow-up

Title

Number of patients experiencig Cardiac death

Description

Time Frame

12-months follow-up

Title

Number of Target-vessel Myocardial infarction

Description

Time Frame

12-months follow-up

Title

Number of Target-lesion revascularization

Description

repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI

Time Frame

12-months follow-up

Title

Number of Stent thrombosis

Description

This is defined according to classification proposed by the Academic Research Consortium

Time Frame

12-months follow-up

Title

Percentage of Device success at 24 hours

Description

deployment of the assigned stents without system failure or device-related complication

Time Frame

24 hours

Title

Percentage of Lesion success at 24 hours

Description

attainment of <50% residual stenosis of the target lesion using post-PCI

Time Frame

24 hours

Title

Percentage of Procedural success at 24 hours

Description

lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥18 Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI. PCI considered appropriate and feasible Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length); Patient provides written informed consent Patient agrees to all required follow-up procedures and visits. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm Exclusion Criteria: The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled); Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum; Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer; Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods; History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions; Previous coronary intervention on target vessel in the 3-months prior to enrollment; Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment); Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; Previously documented left ventricular ejection fraction (LVEF) <30%; Evident cardiogenic shock before randomization; Patients with left main stem stenosis (>50% by visual estimate); In-stent restenosis; ST-segment elevation MI; Chronic total occlusion/ heavily calcified lesions Culprit lesion to a Saphenous Vein graft

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Testa, MD

Organizational Affiliation

IRCCS Policlinico S. Donato

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Policlinico S. Donato

City

San Donato Milanese

State/Province

Milano

ZIP/Postal Code

20097

Country

Italy

Facility Name

Hospital Bellvitge

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31061876

Citation

Testa L, Pero G, Bollati M, Casenghi M, Popolo Rubbio A, Cuman M, Moreno R, Serra A, Gomez JA, Bedogni F. XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial. Int J Cardiol Heart Vasc. 2019 Apr 28;23:100363. doi: 10.1016/j.ijcha.2019.100363. eCollection 2019 Jun.

Results Reference

result

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XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

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